Pain Management and Patient Education for Physical Activity in Intermittent Claudication (PrEPAID)

Summary

Peripheral Arterial disease is a common condition which causes narrowing of the arteries. The most common symptom that patients with PAD experience is Intermittent Claudication (IC), pain in the lower limb(s) on exertion, which is relieved by rest. IC reduces patients' quality of life (QoL) by limiting their ability to walk and engage in daily activities. Regular exercise and physical activity (PA) are central to the management of PAD and help to improve walking distances and reduce the risks associated with PAD such as heart attack and stroke. However, exercise and PA in this population is often limited due to pain. Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS) can help to reduce pain and increase walking distance in patients with PAD. Investigators have also shown that educating patients about their condition and helping them to set goals has the potential to increase PA, and quality of life. This study will examine the feasibility of designing a definitive trial that investigates whether TENS can improve the physical activity of patients with PAD when delivered alone and/or alongside a patient education programme.

Conditions

• Peripheral Arterial Disease
• Intermittent Claudication

Interventions

DEVICE

Active TENS

TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.

BEHAVIORAL

Patient-Centred Education

Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking

DEVICE

Placebo TENS

TENS device use with setting so that the stimulation delivered is ineffective

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• Northumbria University

  collaborator OTHER

• Chief Scientist Office of the Scottish Government

  collaborator OTHER_GOV

• Glasgow Caledonian University

  lead OTHER

Principal Investigators

• Chris Seenan, PT, PhD · Glasgow Caledonian University

• UKACHUKWU ABARAOGU, MSc, PT · Glasgow Caledonian University

• Julie Brittenden, MD, FRCS · Queen Elizabeth University Hospital/University of Glasgow

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-01

Primary Completion

2020-03-24

Completion

2020-03-24

Countries

• United Kingdom

Study Locations